WO2008121615A3 - Antibody formulation - Google Patents

Antibody formulation Download PDF

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Publication number
WO2008121615A3
WO2008121615A3 PCT/US2008/058132 US2008058132W WO2008121615A3 WO 2008121615 A3 WO2008121615 A3 WO 2008121615A3 US 2008058132 W US2008058132 W US 2008058132W WO 2008121615 A3 WO2008121615 A3 WO 2008121615A3
Authority
WO
WIPO (PCT)
Prior art keywords
antibody formulation
antibodies
fragments
invention provides
high concentration
Prior art date
Application number
PCT/US2008/058132
Other languages
French (fr)
Other versions
WO2008121615A2 (en
Inventor
Steven Bishop
Jenny S Wolford
Original Assignee
Medimmune Inc
Steven Bishop
Jenny S Wolford
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US90923207P priority Critical
Priority to US90911707P priority
Priority to US60/909,232 priority
Priority to US60/909,117 priority
Application filed by Medimmune Inc, Steven Bishop, Jenny S Wolford filed Critical Medimmune Inc
Publication of WO2008121615A2 publication Critical patent/WO2008121615A2/en
Publication of WO2008121615A3 publication Critical patent/WO2008121615A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/249Interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification

Abstract

The present invention provides high concentration liquid formulations of antibodies or fragments thereof that specifically bind to a human interferon alpha polypeptide.
PCT/US2008/058132 2007-03-30 2008-03-25 Antibody formulation WO2008121615A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US90923207P true 2007-03-30 2007-03-30
US90911707P true 2007-03-30 2007-03-30
US60/909,232 2007-03-30
US60/909,117 2007-03-30

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US12/593,775 US20100209434A1 (en) 2007-03-30 2008-03-25 Antibody formulation
CN200880017255A CN101678103A (en) 2007-03-30 2008-03-25 antibody formulation
MX2009010389A MX2009010389A (en) 2007-03-30 2008-03-25 Antibody formulation.
AU2008232902A AU2008232902B2 (en) 2007-03-30 2008-03-25 Antibody formulation
BRPI0809674-0A2A BRPI0809674A2 (en) 2007-03-30 2008-03-25 Water formulation, sterile, stable, pharmaceutical unit form, sealed container, kit, method to prevent, control, treat or improve inflammatory disorder, composition, process for preparation, preparation for preparation, preparation and preparation
EP08744323A EP2077859A4 (en) 2007-03-30 2008-03-25 Antibody formulation
RU2009139905/10A RU2491094C2 (en) 2007-03-30 2008-03-25 Antibody preparation
CA002682292A CA2682292A1 (en) 2007-03-30 2008-03-25 Aqueous formulation comprising an anti-human interferon alpha antibody
JP2010501161A JP5456658B2 (en) 2007-03-30 2008-03-25 Antibody preparation
US14/480,145 US20150071943A1 (en) 2007-03-30 2014-09-08 Antibody formulation

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US59377510A A-371-Of-International 2010-04-22 2010-04-22
US14/480,145 Continuation US20150071943A1 (en) 2007-03-30 2014-09-08 Antibody formulation

Publications (2)

Publication Number Publication Date
WO2008121615A2 WO2008121615A2 (en) 2008-10-09
WO2008121615A3 true WO2008121615A3 (en) 2008-12-04

Family

ID=39808854

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2008/058132 WO2008121615A2 (en) 2007-03-30 2008-03-25 Antibody formulation
PCT/US2008/058133 WO2008121616A2 (en) 2007-03-30 2008-03-25 Antibodies with decreased deamidation profiles

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/US2008/058133 WO2008121616A2 (en) 2007-03-30 2008-03-25 Antibodies with decreased deamidation profiles

Country Status (11)

Country Link
US (4) US20100209434A1 (en)
EP (3) EP2703007A1 (en)
JP (2) JP5466635B2 (en)
KR (1) KR101540823B1 (en)
CN (1) CN101678103A (en)
AU (2) AU2008232903B9 (en)
BR (1) BRPI0809674A2 (en)
CA (2) CA2682170A1 (en)
MX (1) MX2009010389A (en)
RU (2) RU2491094C2 (en)
WO (2) WO2008121615A2 (en)

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